Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 63940-971-86
- Packager: Liberty Procurement, Inc
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 27, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warning
- Keep out of reach of children.
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Directions
Adults and children 6 years of age and older:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 mL of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
Children under 6 years of age: consult a dentist or doctor
- Other Information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
This product is not manufactured or distributed by Johnson & Johnson Consumer Inc.,
distributer of Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash
SATISFACTION GUARANTEED
or your money back
Distributed by
Liberty Procurement Co. Inc.
Union, NJ 07083 USA
Visit us at: www.facevalues.com
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Principal Panel Display
CORE VALUES
Compare to Listerine
Zero Alcohol Anticavity
Fluoride Anti-Cavity
MOUTHWASH
Sodium Fluoride and Acidulated Phosphate Topical Solution
anticavity Mouthwash
Helps strengthen teeth to fight cavities
Restores enamel
Kills bad breath germs
Alcohol Free
IMPORTANT:
Read directions for proper use.
Fresh Mint
1 Liter (QT 1.8 FL OZ)
Sealed With Printed Neckband For Your Protection
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-971 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION .2 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) propylene glycol (UNII: 6DC9Q167V3) poloxamer 407 (UNII: TUF2IVW3M2) sodium lauryl sulfate (UNII: 368GB5141J) sodium benzoate (UNII: OJ245FE5EU) phosphoric acid (UNII: E4GA8884NN) eucalyptol (UNII: RV6J6604TK) methyl salicylate (UNII: LAV5U5022Y) thymol (UNII: 3J50XA376E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) menthol (UNII: L7T10EIP3A) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SUCRALOSE (UNII: 96K6UQ3ZD4) SPEARMINT OIL (UNII: C3M81465G5) PEPPERMINT OIL (UNII: AV092KU4JH) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63940-971-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/03/2022 Labeler - Liberty Procurement, Inc (804085293) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63940-971) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63940-971)